The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of the Carrying and Forwarding (C&F) unit operated by drug major Cipla Pharma & Life Sciences Ltd in Pune, citing serious irregularities involving the packaging, storage, documentation and recall procedures for Reactin Plus tablets.
According to the FDA, the cancellation took effect on August 27 following an inspection of the company’s main warehouse located at Wadki in Pune district. The regulatory action relates specifically to the operations of the C&F warehouse.
Cipla has challenged the FDA’s order and stated that the matter is currently sub judice. The company said the proceedings are under judicial consideration and, therefore, it would not be appropriate to comment further at this stage.
Cipla also clarified that the FDA’s order does not raise concerns regarding the safety, quality or efficacy of its products. The company further stated that the action does not involve or indicate any issue concerning patient safety.
The matter is now subject to judicial consideration, while the FDA’s licence cancellation remains in effect from August 27.